EEG Studies of Sevoflurane-Induced General Anesthesia
Electroencephalogram Studies of Induction and Recovery From Sevoflurane-Induced General Anesthesia
1 other identifier
interventional
12
1 country
1
Brief Summary
The investigators are performing this research study to find out how and where the anesthetic drugs sevoflurane and ketamine act in the brain. Sevoflurane and ketamine are anesthetics (a drug or agent used to decrease or eliminate the feeling of pain by causing unconsciousness). The investigators will study the brain using a machine that records the brain's electrical activity, called an electroencephalogram (EEG).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedResults Posted
Study results publicly available
October 24, 2019
CompletedOctober 24, 2019
October 1, 2019
3 months
April 5, 2018
August 2, 2019
October 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Frequencies At Which Changes in Alpha, Theta, and Slow-Delta Wave Power Were Observed From Baseline During Sevoflurane-induced General Anesthesia
Changes in power from baseline at various EEG spectral frequencies were assessed at sevoflurane-induced loss of responsiveness. EEGs of 12 patients were analyzed to determine changes in various EEG spectral frequencies (alpha, theta, delta, etc.) from baseline. The outcome measure reflects the associated frequency (Hz) at which changes were found under sevoflurane-induced general anesthesia. These frequency values are a representation of the findings for all 12 participants.
Approximately 60 minutes
Study Arms (1)
EEG Dynamics
EXPERIMENTALEEG data will be collected on patients receiving sevoflurane, and sevoflurane and ketamine together.
Interventions
Subjects will received sevoflurane and ketamine for approximately 60 minutes.
Eligibility Criteria
You may qualify if:
- Between the ages of 18 and 50
- Normal body weight and habitus, BMI ≤ 30
- Non-smoker
- American Society of Anesthesiologists (ASA) physical status classification P1
You may not qualify if:
- Chronic health conditions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Oluwaseun Johnson-Akeju
- Organization
- Massachusetts General Hospital DACCPM
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Anaesthesia
Study Record Dates
First Submitted
April 5, 2018
First Posted
April 20, 2018
Study Start
May 1, 2018
Primary Completion
August 1, 2018
Study Completion
August 1, 2018
Last Updated
October 24, 2019
Results First Posted
October 24, 2019
Record last verified: 2019-10
Data Sharing
- IPD Sharing
- Will not share